Astellas received a boost just before the Easter break when US advisers recommended approval of its new bladder drug mirabegron.
The US Food and Drug Administration's Reproductive Health Drugs Advisory Committee has voted 7 to 4, with one abstention, that the benefits of mirabegron for the treatment of overactive bladder outweigh the risk. The recommendation came days after FDA staffers had expressed concerns about heart and liver safety issues with the once-daily drug, plus a higher rate of tumours compared to patients on placebo.
Approved in Japan in July last year, as Betanis, mirabegron is a first-in-class beta-3 adrenoceptor agonist and the once-daily tablet facilitates bladder filling and storage of urine. Astellas already markets an OAB treatment, the blockbuster Vesicare (solifenacin).
Steven Ryder, president of Astellas pharma global development, said that if finally approved (a decision is due by June 29), mirabegron will offer "the first new oral mechanism of action in OAB treatment since the launch of the first anticholinergic agent 30 years ago", ie oxybutynin.